Health Law Advisor

FDA has recently partnered with PatientsLikeMe, an online patient networking forum, to leverage patient-reported information to bolster its drug safety monitoring efforts. PatientsLikeMe, with its 350,000 members representing over 2,500 health conditions, has collected more than 110,000 adverse event reports on 1,000 different drugs. This partnership, which is in the form of a research collaboration agreement, will provide FDA with access to "real-world" data about patients' drug and disease experiences (the information provided to FDA is anonymous; so it does not ...

On July 10, 2015, the U.S. Court of Appeals for the District of Columbia Circuit made clear that in False Claims Act cases brought under an implied certification theory, certifying compliance with the federal statute or regulation at issue must be a condition of payment.

In United States ex rel. Davis v. District of Columbia, No. 14-7060, 2015 WL 4153919 (D.C. Cir. Jul. 10, 2015), a qui tam relator alleged that the District of Columbia had failed to maintain certain records supporting certain cost reports it submitted to the District of Columbia Medical Assistance Administration ...

My colleagues Nathaniel M. Glasser and Kristie-Ann M. Yamane (a Summer Associate) at Epstein Becker Green have published a Financial Services Employment Law blog post concerning recent modifications to pregnancy discrimination that will be of interest to many of our readers: “EEOC Updates Pregnancy Discrimination Guidance.”

Following is an excerpt:

In the wake of the U.S. Supreme Court’s decision in Young v. UPS, [1]  the EEOC has modified those aspects of its Enforcement Guidance on Pregnancy Discrimination and Related Issues (“Guidance”) that deal with ...

My colleague Nathaniel M. Glasser recently authored Epstein Becker Green’s Take 5 newsletter.   In this edition of Take 5, Nathaniel highlights five areas of enforcement that U.S. Equal Employment Opportunity Commission (“EEOC”) continues to tout publicly and aggressively pursue.

1. Religious Discrimination and Accommodation—EEOC Is Victorious in New U.S. Supreme Court Ruling
2. Transgender Protections Under Title VII—EEOC Relies on Expanded Sex Discrimination Theories
3. Systemic Investigations and Litigation—EEOC Gives Priority to Enforcement Initiative

In a split decision announced today, June 25, the U.S. Supreme Court, in King v. Burwell, ruled in upholding the tax credits to individuals in all states, including those with only a federal exchange.  In a 6-3 decision, Chief Justice Roberts delivered the opinion of the Court.

"Congress passed the Affordable Care Act to improve health insurance markets, not to destroy them. If at all possible, we must interpret the Act in a way that is consistent with the former, and avoids the latter. Section 36B can fairly be read consistent with what we see as Congress's plan, and that is the reading we ...

On May 1, 2015, we reported on proposed regulations to the Massachusetts paid sick leave law, which becomes effective on July 1, 2015.  The regulations have not yet been adopted, and in light of the uncertainty about many provisions of the law, the Massachusetts Attorney General’s Office has issued a “Safe Harbor for Employers with Existing Paid Time Off Policies.”  Under the safe harbor, any employer with a paid time off policy in existence as of May 1, 2015, which provides employees with the right to use at least 30 hours of paid time off per year, will be deemed in compliance with the ...

Joshua A. Stein, a Member of the Firm in the Labor and Employment practice at Epstein Becker Green, has a Hospitality Labor and Employment Law blog post that will be of interest to many of our readers: "DOJ Further Delays Release of Highly Anticipated Proposed Website Accessibility Regulations for Public Accommodations."

Following is an excerpt:

For those who have been eagerly anticipating the release of the U.S. Department of Justice's proposed website accessibility regulations for public accommodations under Title III of the ADA (the "Public Accommodation Website ...

My colleague Joshua A. Stein at Epstein Becker Green has a Hospitality Labor and Employment Law blog post that will be of interest to many of our readers: “DOJ Further Delays Release of Highly Anticipated Proposed Website Accessibility Regulations for Public Accommodations.”

Following is an excerpt:

For those who have been eagerly anticipating the release of the U.S. Department of Justice’s proposed website accessibility regulations for public accommodations under Title III of the ADA (the “Public Accommodation Website Regulations”), the wait just got even ...

My colleague, Steven M. Swirsky, published a Management Memo post that will be of interest to many of our readers: “First Challenge to NLRB’s New Election Rules Dismissed –Rules Held Constitutional.”

Following is an excerpt:

One of two lawsuits challenging the National Labor Relations Board’s authority to issue the expedited election rules that took effect on April 14, 2015, has now been dismissed by Judge Robert L. Pitman of the United States District Court for the Western District of Texas in Austin.  In his 27 page decision, Judge Pitman that the plaintiffs ...